This Week’s Dose: We saw a flurry of activity this week related to drug pricing, surprise billing, cost containment and tobacco as lawmakers worked through their to-do list ahead of the Memorial Day recess.
HELP’s Long-Awaited Cost Containment Package Arrives. Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) released the draft bill (full text and summary),which builds off a series of hearings held by the HELP Committee last year on the leading drivers of rising health care costs. The bill would prohibit balance billing for emergency services, reduce barriers to generic and biosimilar drugs getting to market, implement new transparency requirements for health plans and pharmacy benefit managers (PBMs), provide new resources for public health initiatives, and improve the availability and interoperability of electronic health information. Perhaps the most notable and surprising provision is one that would prohibit PBMs from engaging in spread pricing and require that they pass on 100 percent of any rebates or discounts to the plan sponsor – essentially ending the current PBM rebate model. Senators Alexander and Murray have indicated that the draft is meant to kick off discussion with other HELP Committee members and ultimately be combined with the Senate Finance Committee’s drug pricing legislation. The Committee is formally accepting comments on the discussion draft through June 5. Alexander has said that he hopes the committee will markup the legislation early this summer in order to get a bill to the President’s desk in July. While the Chairman aspires to move the bill quickly, history suggests this year is moving towards a late fall, early winter health care omnibus inclusive of extenders and other policies being developed, with drug pricing issues being the most unclear at this point.
House Committees Call for Comments on Bipartisan Medicare Part D Legislation. House Ways and Means Committee Chairman Richard Neal (D-MA) and House Energy and Commerce (E&C) Committee Chairman Frank Pallone (D-NJ), along with Ranking Members Kevin Brady (R-TX) and Greg Walden (R-OR), announced a request for comments on draft legislation to reform and improve the Medicare Part D program that would establish an out-of-pocket cap for Medicare beneficiaries. The draft would also reduce the government’s share of the catastrophic coverage from 80 percent to 20 percent over four years in an effort to encourage Part D plans to better manage costs. The committee is formally accepting comments on the draft until June 6.
A Busy Week for Hearings before Lawmakers Head Home.
Senate Finance Seeks Insulin Cost Data from CMS. Senate Finance Committee Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma seeking a broad set of data relating to insulin costs. Specifically, the letter asks for information on insulin reimbursements paid by the federal government, out-of-pocket costs for patients, total prescription volumes for insulin and insulin rebate programs fees. The senators focused on the patient and taxpayer impact with respect to Medicare Parts B and D, Medicaid and the Children’s Health Insurance Program. The Finance Committee’s investigation into insulin prices began in February with inquiries to the three primary manufacturers of the drug, and the focus is sure to continue.
New Legislation to Raise Tobacco Purchase Age. Senate Majority Leader Mitch McConnell (R-KY) and Senator Tim Kaine (D-VA) introduced legislation that raises the national minimum age to purchase tobacco products from 18 to 21. The Tobacco-Free Youth Act resembles other recent bipartisan bills (as well as similar legislation approved by a number of states) that raise the minimum purchase age to 21, but it is significant because McConnell, who hails from a tobacco producing state, has stated that raising the age for the purchase of tobacco is one his highest priorities. It is important to remember that this proposal will produce a CBO score, and something will have to pay for the losses in federal tax revenue. Nevertheless, expect this to move quickly in the Senate.
Administration Releases Its Spring Regulatory Agenda. The Administration released the spring regulatory agenda, which reports on the regulatory actions federal agencies plan to issue in the short and long term. Some notable proposals include a proposed rule to increase accountability, transparency and clarity through improved Medicaid payment reporting, a proposed rule supporting value-based payments for drugs covered in Medicaid, and long-rumored proposed rules updating the Stark Law and Anti-Kickback Statute. Additionally, the International Pricing Index model is now expected to be proposed in August, and the final rule to require that rebates be passed through to consumers in Medicare Part D and Medicaid managed care is likely in November, both later than previously anticipated. Also of note, the proposed rule regarding non-emergency medical transportation, which had been in previous regulatory agendas, was missing from the spring list. While the agenda does not set an exact timeline, it does give stakeholders an idea of the Administration’s priorities.
GAO Calls for Greater Transparency in Medicaid Waivers. The Government Accountability Office (GAO) released its report Medicaid Demonstrations: Approvals of Major Changes Need Increased Transparency. In this report, GAO examined CMS’s transparency policies and procedures for section 1115 Medicaid waivers. The report found weaknesses in CMS’s policies or procedures for ensuring transparency in approvals of new demonstrations and extensions of existing demonstrations, including the transparency of major changes made to pending applications and approved spending limits. CMS also inconsistently reviewed applications for compliance with transparency requirements for new demonstrations and extensions. GAO made two recommendations to address these concerns: 1) develop policies that define when changes to a pending section 1115 demonstration application are considered major and require a new application, and 2) develop transparency requirements for amendments that may have significant impact. The Department of Health and Human Services (HHS) concurred with these recommendations.
Canadian Drug Importation and Surprise Billing. While Congress continues crafting federal legislation to lower drug prices and address surprise billing, states are passing their own versions. The longer this takes at the federal level, the more preemption will become a sticking point.
Next Week’s Diagnosis: It’s time to enjoy the Memorial Day recess.
To subscribe to the McDermottPlus Check-Up, please contact Jennifer Randles.